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Surgical vs Endovascular Management for Brain Aneurysm (ISATII Trial)

N/A
Waitlist Available
Led By Jean Raymond, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients at least 18 years of age
SAH WFNS grade 4 or less
Must not have
Patients with AVM-associated aneurysms
Aneurysm located at basilar apex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year and five years
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two different ways to fix a burst brain aneurysm in people not previously included in a study.

Who is the study for?
This trial is for adults over 18 with a documented brain aneurysm that has ruptured in the last month. They should be stable enough to undergo surgery or endovascular treatment, as judged by their medical team. People can't join if they're allergic to contrast material used in scans, have aneurysms linked to arteriovenous malformations (AVMs), or if the aneurysm is at the basilar apex.
What is being tested?
The study aims to compare two treatments for ruptured brain aneurysms: surgical clipping and endovascular coiling. These are different methods of preventing further bleeding from the weakened blood vessel area in the brain.
What are the potential side effects?
Potential side effects may include complications related to surgery such as infection, reaction to anesthesia, stroke, re-bleeding of the aneurysm and neurological deficits. Endovascular treatment risks could involve damage to blood vessels, bleeding or clotting issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My brain hemorrhage is not the most severe grade.
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I had a brain aneurysm rupture in the last 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have aneurysms linked to my AVM condition.
Select...
My aneurysm is located at the top part of the basilar artery.
Select...
I cannot receive contrast material due to severe allergies or other health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
poor clinical outcome(mRS>2)
Secondary study objectives
Failure of aneurysm occlusion using the intended treatment modality
Occurence of a "major" (saccular) aneurysm recurrence
Occurence of aneurysm re-rupture following randomization but before treatment initiation
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Surgical managementActive Control1 Intervention
Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
Group II: Endovascular managementActive Control1 Intervention
Endovascular treatment will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
129,656 Total Patients Enrolled
14 Trials studying Aneurysm
3,926 Patients Enrolled for Aneurysm
Jean Raymond, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
9 Previous Clinical Trials
2,591 Total Patients Enrolled
6 Trials studying Aneurysm
1,109 Patients Enrolled for Aneurysm
Tim Darsaut, MDPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
2,291 Total Patients Enrolled
2 Trials studying Aneurysm
2,291 Patients Enrolled for Aneurysm

Media Library

Endovascular management (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01668563 — N/A
Aneurysm Research Study Groups: Surgical management, Endovascular management
Aneurysm Clinical Trial 2023: Endovascular management Highlights & Side Effects. Trial Name: NCT01668563 — N/A
Endovascular management (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01668563 — N/A
~12 spots leftby Dec 2024
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